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Efficacy of Essential Oil Mouthwash With and Without Alcohol: a 3-Day Plaque Accumulation Model

Primary Purpose

Gingivitis, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
free alcohol essential oil mouthwash
Sponsored by
University of L'Aquila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring Antiplaque agents, chemical plaque control, oral hygiene, essential oils, alcohol, mouthwash

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • a dentition with ≥20 evaluable teeth (minimum of five teeth per quadrant),
  • no oral lesions
  • no severe periodontal problems (no probing depth ≥5 mm)
  • no removable prostheses or orthodontic bands or appliances

Exclusion Criteria:

  • allergies to several mouthwash components

Sites / Locations

  • University of L'Aquila, Division of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

free alcohol essential oil moutwash

alcohol containing essential oil mouthwash

Arm Description

Outcomes

Primary Outcome Measures

difference between the two groups using the Plaque Index by Quigley and Hein modified by Turesky

Secondary Outcome Measures

Full Information

First Posted
August 5, 2011
Last Updated
August 5, 2011
Sponsor
University of L'Aquila
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1. Study Identification

Unique Protocol Identification Number
NCT01411618
Brief Title
Efficacy of Essential Oil Mouthwash With and Without Alcohol: a 3-Day Plaque Accumulation Model
Official Title
Efficacy of Essential Oil Mouthwash With and Without Alcohol: a 3-Day Plaque Accumulation Model
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of L'Aquila

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The daily removal of supragingival dental plaque is a major factor in the prevention of caries, gingivitis and periodontitis. Proper control of bacterial plaque is obtained through the mechanical removal of the biofilm by the proper use of the toothbrush and floss. However, some studies have shown that the mean time of brushing tooth surfaces is less than that required to obtain a proper cleaning 1 and only 2-10% of the patients use dental floss regularly and effectively 2. In addition, it has been demonstrated that even after education and motivation of the patient to the proper use of toothbrush and floss, its compliance is reduced with time 3. The result is the persistence of plaque in some areas, particularly on the interproximal surfaces of teeth. Many studies have demonstrated the effectiveness and usefulness of antiseptic mouthwashes containing active ingredients such as chlorhexidine (CHX) and essential oils (EO) to prevent and control the formation of plaque and gingivitis, when used in addition to mechanical procedures 4-7. Chlorhexidine is still the gold standard for its antimicrobial action and high substantiveness, but side effects, such as pigmentation, taste alteration and the formation of supragingival calculus limit its continued use 8. Essential oil (EO) mouthwashes have been used for years as an adjunct to brushing in addressing oral hygiene. Their effectiveness in controlling plaque and gingivitis are well documented in literature 9-14. They kill microorganisms by destroying their cell walls and inhibiting their enzymatic activity 15,16. Furthermore, phenolic compounds like EOs are known to interfere with the inflammation process 17,18. The antibacterial action is particularly effective for the ability of the mouthwash with EOs to penetrate the biofilm 19-21. The traditional EO mouthwashes contain ethanol, a chemical used to dissolve numerous substances in mouthwashes, including CHX. The concentration of ethanol present in the mouthwash with EOs is more than 20%, sufficient to dissolve the EOs but not enough to carry out a direct antibacterial effect 22,23. Many aspects against the use of alcohol in mouthwashes, such as its effects on the surfaces of composite restorations 24 and its possible role in the formation of oropharyngeal cancer are being discussed 25,26. Although a direct correlation of the cause and effect between the occurrence of oropharyngeal cancer and the use of mouthwashes with alcohol 27, has not demonstrated so far, it is considered desirable to eliminate ethanol for use in daily mouthwash, bringing in search of new formulations. Recently, an EOs containing mouthwash without alcohol was introduced on the European market (Daycare, Curaden, Kriens, and Suisse). To our knowledge, to date there are no published data on the effectiveness of this antimicrobial product. The rinsing with this mouthwash can cause fewer side effects but, in contrast, it may be less effective. The aim of this study was to evaluate the inhibitory properties of a new alcohol free EO containing mouthwash with respect to the traditional mouthwash containing 21.3% ethanol, through a standard 3-days plaque regrowth model.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Periodontitis
Keywords
Antiplaque agents, chemical plaque control, oral hygiene, essential oils, alcohol, mouthwash

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
free alcohol essential oil moutwash
Arm Type
Experimental
Arm Title
alcohol containing essential oil mouthwash
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
free alcohol essential oil mouthwash
Intervention Description
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 20 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Primary Outcome Measure Information:
Title
difference between the two groups using the Plaque Index by Quigley and Hein modified by Turesky
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: a dentition with ≥20 evaluable teeth (minimum of five teeth per quadrant), no oral lesions no severe periodontal problems (no probing depth ≥5 mm) no removable prostheses or orthodontic bands or appliances Exclusion Criteria: allergies to several mouthwash components
Facility Information:
Facility Name
University of L'Aquila, Division of Periodontology
City
L'aquila
State/Province
AQ
ZIP/Postal Code
67100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22171999
Citation
Marchetti E, Mummolo S, Di Mattia J, Casalena F, Di Martino S, Mattei A, Marzo G. Efficacy of essential oil mouthwash with and without alcohol: a 3-day plaque accumulation model. Trials. 2011 Dec 15;12:262. doi: 10.1186/1745-6215-12-262.
Results Reference
derived

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Efficacy of Essential Oil Mouthwash With and Without Alcohol: a 3-Day Plaque Accumulation Model

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